Transcription of Quality Management System
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Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers integrating GMP (ICH Q7a) into ISO (9001: 2000) September 2005 APIC / CEFIC Quality Management System - integrating GMP (ICH Q7a) into ISO (9001: 2000) Page 2 of 73 Table of Contents I. Introduction II. Objective and Scope III. Quality Management Systems for API manufacturers 1. Quality Management System 2. Management responsibility 3. Resource Management 4. Product realization (Manufacturing Operations) 5. Measurement, analysis and improvement (Evaluation Activities) IV. Supplementary Information 1.
Active Pharmaceutical Ingredients” has some fundamentally different GMP requirements, and specifically applies to the manufacture of APIs for use in drug (medicinal) products. The guide covers APIs manufactured by chemical synthesis, extraction, cell culture/fermentation, by recovery from natural sources, or by any combination of these processes.
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